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Patent 2821209 Summary

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(12) Patent Application: (11) CA 2821209
(54) English Title: NEEDLE ASSEMBLY FOR DRUG DELIVERY DEVICES
(54) French Title: ENSEMBLE D'AIGUILLE POUR DISPOSITIFS D'ADMINISTRATION DE MEDICAMENT
Status: Dead
Bibliographic Data
(51) International Patent Classification (IPC):
  • A61M 5/34 (2006.01)
(72) Inventors :
  • JUGL, MICHAEL (Germany)
  • TEUCHER, AXEL (Germany)
(73) Owners :
  • SANOFI-AVENTIS DEUTSCHLAND GMBH (Germany)
(71) Applicants :
  • SANOFI-AVENTIS DEUTSCHLAND GMBH (Germany)
(74) Agent: BERESKIN & PARR LLP/S.E.N.C.R.L.,S.R.L.
(74) Associate agent:
(45) Issued:
(86) PCT Filing Date: 2011-12-08
(87) Open to Public Inspection: 2012-06-21
Availability of licence: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): Yes
(86) PCT Filing Number: PCT/EP2011/072236
(87) International Publication Number: WO2012/080086
(85) National Entry: 2013-06-11

(30) Application Priority Data:
Application No. Country/Territory Date
10194647.3 European Patent Office (EPO) 2010-12-13

Abstracts

English Abstract

The present invention relates A needle assembly for a drug delivery device comprising: - a cup-shaped receptacle (14) of non-circular cross section having a bottom section (16) supporting a needle element (20) being adapted to penetrate a pierceable seal of a cartridge to be disposed in a cartridge holder (10) of the drug delivery device, - wherein the receptacle (14) comprises fastening means (26, 27) adapted to engage with fastening means (24, 25) of a support section (11) of the cartridge holder (10) for releasably fastening the needle assembly, - wherein the fastening means (24, 25, 26, 27) are convertible into a release configuration by changing the radial distance of mutually corresponding fastening means (24, 25, 26,27) through twisting the receptacle (14) with respect to the support section (11).


French Abstract

La présente invention concerne un ensemble d'aiguille pour un dispositif d'administration de médicament, qui comprend : - un réceptacle en forme de coupe (14) de section transversale non circulaire et ayant une section inférieure (16) supportant un élément d'aiguille (20) adapté à pénétrer un opercule pouvant être percé d'une cartouche à placer dans un support de cartouche (10) du dispositif d'administration de médicament, - le réceptacle (14) comprenant un moyen de fixation (26, 27) adapté à se mettre en prise avec un moyen de fixation (24, 25) d'une section de support (11) du support de cartouche (10) pour fixer de manière libérable l'ensemble d'aiguille, - les moyens de fixation (24, 25, 26, 27) pouvant passer à une configuration de libération par modification de la distance radiale des moyens de fixation mutuellement correspondants (24, 25, 26, 27) par torsion du réceptacle (14) relativement à la section de support (11).

Claims

Note: Claims are shown in the official language in which they were submitted.


16
Claims
1. A needle assembly for a drug delivery device comprising:
- a cup-shaped receptacle (14) of non-circular cross section having a
bottom section (16) supporting a needle element (20) being adapted to
penetrate a pierceable seal of a cartridge to be disposed in a cartridge
holder (10) of the drug delivery device,
- wherein the receptacle (14) comprises fastening means (26, 27)
adapted to engage with fastening means (24, 25) of a support section (11) of
the cartridge holder (10) for releasably fastening the needle assembly,
- wherein the fastening means (24, 25, 26, 27) are convertible into a
release configuration by changing the radial distance of mutually
corresponding fastening means (24, 25, 26,27) through twisting the
receptacle (14) with respect to the support section (11).
2. The needle assembly according to claim 1, wherein the receptacle (14)
comprises an oval cross section.
3. The needle assembly according to claim 1 or 2, wherein the fastening
means
(24, 25, 26, 27) of cartridge holder support section (11) and receptacle (14)
are adapted to form a positive interlock.
4. The needle assembly according to any one of the preceding claims,
wherein
the receptacle (14) is elastically deformable.
5. The needle assembly according to any one of the preceding claims,
wherein
the fastening means of the receptacle(14) comprise two radially inwardly

17
protruding latching elements (26, 27).
6. The needle assembly according to claim 5, wherein the latching element
(26,
27) are arranged on opposite endpoints of an imaginary long axis of the oval
receptacle (14).
7. The needle assembly according to claim 5, wherein the latching elements
(26, 27) comprise a bevelled surface facing towards an insertion direction.
8. A cartridge holder subassembly for a drug delivery device comprising
- a cartridge holder (10) adapted to receive a cartridge filled with a
medicament to be dispensed by the drug delivery device, wherein the
cartridge comprises a pierceable seal at a distal end portion,
- a support section (11) for a needle assembly according to any one of
the preceding claims, wherein the support section (11) comprises a non-
circular cross-section, and
- fastening means (24, 25) adapted to form a positive interlock with
corresponding fastening means (26 ,27) of the needle assembly.
9. The cartridge holder according to claim 8, wherein the support section
(11)
comprises an oval cross section that corresponds with the cross section of
the receptacle (14) of the needle assembly (12).
10. The cartridge holder subassembly according to claim 8 or 9, wherein the

fastening means of the support section (11) comprise at least two radially
outwardly protruding ribs (24, 25) adapted to engage with corresponding
latching elements (26, 27 ) of the needle assembly (12).

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11. The cartridge holder subassembly according to claim 10, wherein the
latching elements (24, 25) are arranged on opposite endpoints of a long axis
of the oval receptacle (14).
12. A drug delivery device for administering a dose of medicament,
comprising:
- a housing,
- a drive mechanism to be operably engaged with a piston of a cartridge
for dispensing of a pre-defined dose of a medicament contained in said
cartridge,
- a cartridge holder (10) according to any one of the preceding claims 8
to 11,
- a cartridge displaced in the cartridge holder (10) and being filled with
the medicament, and
- a needle assembly (12) according to any one of the preceding claims
1 to 7.
13. A method of releasably fastening a needle assembly to a cartridge
holder of
a drug delivery device, wherein the needle assembly comprises a cup-
shaped receptacle (14) of non-circular cross-section comprising a bottom
section (16) supporting a needle element (20), wherein fastening of the
needle assembly (12) to the cartridge holder (10) comprises the steps of:
- inserting a distal support section (11) of the cartridge holder (10) of
non-circular cross section into the cup-shaped receptacle (14) by displacing
the receptacle (14) translationally relative to the cartridge holder (10) in
proximal direction and engaging mutually corresponding fastening means
(24, 25, 26, 27) of cartridge holder (10) and receptacle (14) by changing the

19
radial distance of the fastening means (24, 25, 26, 27) through twisting the
receptacle (14) with respect to the support section (11).
14. The method according to claim 13, wherein disassembling of needle
assembly (12) and cartridge holder (10) comprises the steps of:
twisting the needle assembly (12) with respect to the cartridge holder
(10) for changing the radial distance of the mutually corresponding fastening
means (24, 25, 26,27) and for converting said fastening means (24, 25,
26,27) into a release configuration.

Description

Note: Descriptions are shown in the official language in which they were submitted.


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Description
Needle Assembly for Drug Delivery Devices
Description
The present invention relates to a drug delivery device and in particular to a
needle
assembly to be interconnected to a cartridge holding section of a drug
delivery device.
Background and Prior Art
Drug delivery devices allowing for multiple dosing of a required dosage of a
liquid
medicament, such as liquid drugs, and further providing administration of the
liquid to a
patient, are as such well-known in the art. Generally, such devices have
substantially
the same purpose as that of an ordinary syringe.
Drug delivery devices of this kind have to meet a number of user specific
requirements.
For instance in case of those with diabetes, many users will be physically
infirm and
may also have impaired vision. Therefore, these devices need to be robust in
construction, yet easy to use, both in terms of the manipulation of the parts
and
understanding by a user of its operation. Further, the dose setting must be
easy and
unambiguous and where the device is to be disposable rather than reusable, the
device
should be inexpensive to manufacture and easy to dispose.
In order to meet these requirements, the number of parts and steps required to

assemble the device and an overall number of material types the device is made
from
have to be kept to a minimum.
Typically, the medicament to be administered is provided in a cartridge that
has a
moveable piston or bung mechanically interacting with a piston rod of a drive

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mechanism of the drug delivery device. By applying thrust to the piston in
distal
direction, a certain amount of the medicinal fluid is expelled from the
cartridge.
Drug delivery devices, such like pen-type injectors typically comprise a
housing having
a cartridge holder for receiving the cartridge filled with the medicament that
has to be
dispensed. The distal end section of a cartridge holder facing towards the
patient during
an injector procedure typically comprises a through opening that provides
access to a
sealed distal end of the cartridge. By way of said through opening, an
injection needle
or cannula may penetrate the elastic seal to establish a fluid interconnect
allowing the
medicament to be expelled from the cartridge.
Typically, the disposable injection needle is provided by way of a needle
assembly for
releasably fastening the injection needle to the cartridge holder. For this
purpose,
needle assembly and distal end section of the cartridge holder comprise
mutually
corresponding threads, by way of which the needle assembly is screwed onto the
cartridge holder. However, a threaded connection of cartridge holder and
needle mount
comes along with a number of deficiencies. Such threaded engagement for
instance,
does not give a perceptible feedback to the user whether needle assembly is
securely
mounted on the cartridge holder. In practical use, situations may occur, that
only a
single or a few threads of a cartridge holder and a needle assembly inter-
engage, but
the needle assembly is not yet securely fastened to the cartridge holder.
A user may then simply not be not aware of such improper and insufficient
fastening
and may therefore initiate a dose selecting and dispensing procedure. In
particular in
the course of a dispensing of a dose of the medicament, the needle assembly
may
autonomously disengage from the cartridge holder, for instance due to a built-
up of a
fluid pressure and/or when penetrating the skin of the patient. In these
cases, the
patient would be exposed to an increased health risk.
Object of the Invention

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It is therefore an object of the present invention, to provide an improved
fastening
mechanism for a needle assembly and to provide an unambiguous mutual
mechanical
engagement of cartridge holder and needle assembly. In another object, the
invention
The present invention provides a needle assembly for a drug delivery device
that
comprises a cup-shaped receptacle of non-circular cross section. The cup-
shaped
receptacle further has a bottom section supporting a needle element.
Preferably, the
The drug delivery device typically comprises a housing and a drive mechanism
to be
dispensed by the device. The housing comprises a cartridge holder or a
cartridge holder
section and may comprise multiple housing components, such as a main housing
component adapted to accommodate the drive mechanism. The cartridge holder or
the
cartridge holder section is adapted to receive the cartridge.
Irrespective on whether the drug delivery device comprises a single- or multi-
component
housing, the cartridge holder or cartridge holder section at its distal end is
adapted to
receive and to support the needle assembly according to the present invention.
away from the cartridge, said needle element is adapted to penetrate
biological tissue,
in particular the skin of a patient for administering of the medicament.

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The cup-shaped receptacle further comprises fastening means adapted to engage
with
corresponding fastening means of a support section of the cartridge holder for
releasable fastening the needle assembly to the cartridge holder. Furthermore,
the
fastening means are convertible into a release configuration by changing the
radial
distance of mutually corresponding fastening means through twisting the
receptacle with
respect to the cartridge holder support section. Preferably, the receptacle is
twisted with
respect to the long axis of the cartridge holder or the drug delivery device.
Hence, the
central axis of the generally cylindrically shape drug delivery device serves
as rotation-
or twisting axes in order to engage and/or disengage fastening means of needle
assembly and cartridge holder.
Since the cup-shaped receptacle of the needle assembly comprises a non-
circular cross
section, by twisting the receptacle, radial overlap of mutually corresponding
fastening
means can be modified such that the fastening means of receptacle and
cartridge
holder disengage.
Preferably, the receptacle comprises an oval or elliptic cross section.
Alternatively, it is
also conceivable, that the receptacle is of rectangular or polygonal shape.
Additionally,
the cup-shaped receptacle can be elastically deformable thereby allowing to
modify a
relative angle of orientation of cup-shaped receptacle and cartridge holder
support
section.
In a further aspect, the fastening means of the cartridge holder support
section and of
the receptacle are adapted to form a positive interlock. Such positive
engagement of
mutually corresponding fastening means allows for a quick, reliable and
releasable
fastening of needle assembly and cartridge holder of the drug delivery device.
In a another embodiment, the fastening means of the receptacle comprise two
radially
inwardly protruding latching elements. By way of the latching elements, a snap-
fit
interconnect of needle assembly and cartridge holder can be established. In
particular,
an interconnection of needle assembly and cartridge holder can be generally
attained

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by pushing the cup-shaped receptacle onto the support section of the cartridge
holder
until the latching elements reach their final assembly configuration.
Preferably,
accomplishing of a final assembly configuration is accompanied by some
perceptible
feedback, like an audible or haptic clicking.
5
In another embodiment, the latching elements comprise a bevelled face pointing

towards a direction of assembly. When assembling needle assembly and cartridge

holder, the bevelled face of the latching elements may support temporal
elastic
deformation of the oval receptacle. Moreover, by way of the bevelled faces, a
snap fit of
the mutually corresponding latching elements can be attained. In effect,
fastening of
needle assembly and cartridge holder can be conducted in such a way, that the
needle
assembly is simply translationally displaced relative to the cartridge holder
in proximal
direction, i.e. towards the piston of the cartridge even without inducing any
twisting or
turning motion.
In another independent aspect, the invention further relates to a cartridge
holder
subassembly for a drug delivery device, wherein the cartridge holder
subassembly
comprises a cartridge holder adapted to receive a cartridge filled with a
medicament to
be dispensed by the drug delivery device. A cartridge typically comprises a
pierceable
seal at a distal end portion and also has an axially displaceable piston at is
opposite
proximal end portion. Said piston is adapted to become operably engaged with a
piston
rod of a drive mechanism of the drug delivery device, which is adapted to
exert distally
directed pressure on said piston for the purpose of expelling a pre-defined
dose of the
medicinal fluid.
The cartridge holder further comprises a support for a needle assembly,
wherein the
support features a non-circular cross section.
Furthermore, the cartridge holder or cartridge holder subassembly comprises
fastening
means adapted to form a positive interlock with corresponding fastening means
of the
needle assembly. In particular, the cartridge holder subassembly is formed by
assembling the needle assembly to the cartridge holder.

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The non-circular cross-section of the support section of the cartridge holder
preferably
corresponds to the geometry and to the non-circular cross section of the cup-
shaped
receptacle of the needle assembly. Cartridge holder and needle assembly can
only be
attached and fastened to each other in a preferential direction due to their
non-circular
cross-section. Hence, the non-circular cross section prevents mutual fastening
of
needle assembly and cartridge holder in arbitrary rotative orientations.
Preferably, also the support section of the cartridge holder comprises an oval
cross
section that corresponds with the cross section of the receptacle of the
needle assembly.
Preferably, the overall cross-sectional surface of the support section is
smaller than the
comparable cross-sectional surface of the receptacle. In this way, the distal
end of the
support section can be at least partially inserted into the receptacle of the
needle
assembly.
Since receptacle and support section of the cartridge holder comprise
substantially
corresponding cross sections, depending on their difference with respect to
inner and
outer diameters and their particular shape of their respective cross sections,
a relative
twisting of receptacle and support section of the cartridge holder is only
possible within
a predefined angular range. Geometric design of mutually corresponding
fastening
elements and the difference in diameter of the support section and the
receptacle is
chosen in such a way, that the fastening means at least disengage when a
maximum
allowable relative angle of rotation of support section and receptacle is
reached.
According to a further preferred embodiment, the fastening means of the
support
section comprise at least two radially outwardly protruding elements adapted
to engage
with corresponding latching elements of the needle assembly. Preferably, the
radially
outwardly protruding fastening elements of the cartridge holder subassembly
only
extend within predefined margins in circumferential direction. By way of
introducing a
relative twist of receptacle and support section, mutually engaging fastening
elements
can be effectively disengaged.

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Preferably, the radially outwardly protruding fastening elements of the
cartridge holder
subassembly comprise a radially extending rib inter-engaging with the radially
inwardly
protruding latching element of the receptacle of the needle assembly.
In a further preferred embodiment, the latching elements of the cartridge
holder are
arranged at opposite endpoints of the ovally shaped support section.
In another independent aspect, the invention also relates to a drug delivery
device
adapted for administering a dose of a medicament. The drug delivery device
comprises
a housing, a drive mechanism to be operably engaged with a piston of a
cartridge for
dispensing of a pre-defined dose of a medicament contained in said cartridge.
The drug
delivery device further comprises a cartridge holder and a respective
cartridge displaced
therein, which is filled with the medicament to be dispensed. Moreover, the
drug
delivery device comprises a needle assembly as described above attached or
being
attachable to the cartridge holder in a way as suggested by the present
invention.
In still another aspect, the invention refers to a method of releasably
fastening a needle
assembly to a cartridge holder of a drug delivery device, wherein the needle
assembly
comprises a cup-shaped receptacle of non-circular cross section.
The receptacle further has a bottom section supporting or embedding a needle
element
adapted to pierce a distally located seal of the cartridge. Fastening of the
needle
assembly to the cartridge holder comprises inserting a distal support section
of the
cartridge holder of non-circular cross section into the cup-shaped receptacle
of non-
circular cross section by displacing the receptacle translationally relative
to the cartridge
holder in axial and proximal direction.
Subsequently, corresponding fastening means of cartridge holder and receptacle
are to
be mutually engaged by changing the radial distance of the corresponding
fastening
means by way of twisting the receptacle with respect to the support section,
wherein the
axis of twisting substantially corresponds to the long axis of the cartridge
holder of the
drug delivery device.

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Furthermore and according to another embodiment, for a disassembly of needle
assembly and cartridge holder, the needle assembly is twisted with respect to
the
cartridge holder for changing the radial distance of the mutually
corresponding fastening
means, thereby converting the fastening means into a release configuration,
which
allows to remove the needle assembly from the cartridge holder in distal
direction, i.e.
by translationally displacing the needle assembly away from the distal support
section of
the cartridge holder.
The term õmedicament", as used herein, means a pharmaceutical formulation
containing at least one pharmaceutically active compound,
wherein in one embodiment the pharmaceutically active compound has a molecular

weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a
vaccine, a
DNA, a RNA, a antibody, an enzyme, an antibody, a hormone or an
oligonucleotide, or
a mixture of the above-mentioned pharmaceutically active compound,
wherein in a further embodiment the pharmaceutically active compound is useful
for the
treatment and/or prophylaxis of diabetes mellitus or complications associated
with
diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such
as
deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina,

myocardial infarction, cancer, macular degeneration, inflammation, hay fever,
atherosclerosis and/or rheumatoid arthritis,
wherein in a further embodiment the pharmaceutically active compound comprises
at
least one peptide for the treatment and/or prophylaxis of diabetes mellitus or

complications associated with diabetes mellitus such as diabetic retinopathy,
wherein in a further embodiment the pharmaceutically active compound comprises
at
least one human insulin or a human insulin analogue or derivative, glucagon-
like
peptide (GLP-1) or an analogue or derivative thereof, or exedin-3 or exedin-4
or an
analogue or derivative of exedin-3 or exedin-4.

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Insulin analogues are for example Gly(A21), Arg(B31), Arg(B32) human insulin;
Lys(B3),
Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human
insulin;
human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu,
Val or Ala
and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human
insulin;
Des(B28-630) human insulin; Des(B27) human insulin and Des(B30) human insulin.
Insulin derivates are for example B29-N-myristoyl-des(B30) human insulin; B29-
N-
palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-
palmitoyl
human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-
LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-
palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-Y-glutamy1)-des(B30)

human insulin; B29-N-(N-lithocholyl-Y-glutamyI)-des(B30) human insulin; B29-N-
(w-
carboxyheptadecanoy1)-des(B30) human insulin and B29-N-(w-carboxyhepta-
idecanoyl)
human insulin.
Exendin-4 for example means Exendin-4(1-39), a peptide of the sequence H His-
Gly-
Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-
Phe-
Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.
Exendin-4 derivatives are for example selected from the following list of
compounds:
H-(Lys)4-des Pro36, des Pro37 Exendin-4(1-39)-NH2,
H-(Lys)5-des Pro36, des Pro37 Exendin-4(1-39)-NH2,
des Pro36 [Asp28] Exendin-4(1-39),
des Pro36 [IsoAsp28] Exendin-4(1-39),
des Pro36 [Met(0)14, Asp28] Exendin-4(1-39),
des Pro36 [Met(0)14, IsoAsp28] Exendin-4(1-39),
des Pro36 [Trp(02)25, Asp28] Exendin-4(1-39),
des Pro36 [Trp(02)25, IsoAsp28] Exendin-4(1-39),
des Pro36 [Met(0)14 Trp(02)25, Asp28] Exendin-4(1-39),
des Pro36 [Met(0)14 Trp(02)25, IsoAsp28] Exendin-4(1-39); or

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des Pro36 [Asp28] Exendin-4(1-39),
des Pro36 [IsoAsp28] Exendin-4(1-39),
des Pro36 [Met(0)14, Asp28] Exendin-4(1-39),
5 des Pro36 [Met(0)14, IsoAsp28] Exendin-4(1-39),
des Pro36 [Trp(02)25, Asp28] Exendin-4(1-39),
des Pro36 [Trp(02)25, IsoAsp28] Exendin-4(1-39),
des Pro36 [Met(0)14 Trp(02)25, Asp28] Exendin-4(1-39),
des Pro36 [Met(0)14 Trp(02)25, IsoAsp28] Exendin-4(1-39),
10 wherein the group -Lys6-NH2 may be bound to the C-terminus of the
Exendin-4
derivative;
or an Exendin-4 derivative of the sequence
H-(Lys)6-des Pro36 [Asp28] Exendin-4(1-39)-Lys6-NH2,
des Asp28 Pro36, Pro37, Pro38Exendin-4(1-39)-NH2,
H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1-39)-NH2,
H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-NH2,
des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36 [Trp(02)25, Asp28] Exendin-4(1-39)-Lys6-NH2,
H-des Asp28 Pro36, Pro37, Pro38 [Trp(02)25] Exendin-4(1-39)-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1-39)-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1-39)-NH2,
des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1-39)-(Lys)6-
NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1-39)-(Lys)6-
NH2,
H-(Lys)6-des Pro36 [Met(0)14, Asp28] Exendin-4(1-39)-Lys6-NH2,
des Met(0)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1-39)-NH2,
H-(Lys)6-desPro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1-39)-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1-39)-NH2,
des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2,

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H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2,

H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1-39)-(Lys)6-
NH2,
H-Lys6-des Pro36 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1-39)-Lys6-NH2,
H-des Asp28 Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25] Exendin-4(1-39)-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1-39)-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1-
39)-
NH2,
des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1-39)-(Lys)6-
NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(S1-39)-

(Lys)6-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1-
39)-
(Lys)6-NH2;
or a pharmaceutically acceptable salt or solvate of any one of the afore-
mentioned
Exedin-4 derivative.
Hormones are for example hypophysis hormones or hypothalamus hormones or
regulatory active peptides and their antagonists as listed in Rote Liste, ed.
2008,
Chapter 50, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin,
Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin,
Gonadorelin,
Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.
A polysaccharide is for example a glucosaminoglycane, a hyaluronic acid, a
heparin, a
low molecular weight heparin or an ultra low molecular weight heparin or a
derivative
thereof, or a sulphated, e.g. a poly-sulphated form of the above-mentioned
polysaccharides, and/or a pharmaceutically acceptable salt thereof. An example
of a
pharmaceutically acceptable salt of a poly-sulphated low molecular weight
heparin is
enoxaparin sodium.
Pharmaceutically acceptable salts are for example acid addition salts and
basic salts.
Acid addition salts are e.g. HCI or HBr salts. Basic salts are e.g. salts
having a cation
selected from alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion

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12
N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently of each other mean:
hydrogen,
an optionally substituted Cl C6-alkyl group, an optionally substituted C2-C6-
alkenyl
group, an optionally substituted C6-C10-aryl group, or an optionally
substituted C6-C10-
heteroaryl group. Further examples of pharmaceutically acceptable salts are
described
in "Remington's Pharmaceutical Sciences" 17. ed. Alfonso R. Gennaro (Ed.),
Mark
Publishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia of
Pharmaceutical
Technology.
Pharmaceutically acceptable solvates are for example hydrates.
It will be apparent to those skilled in the pertinent art, that various
modifications and
variations can be made to the present invention without departing from the
spirit and
scope of the invention. Further, it is to be noted, that any reference signs
used in the
appended claims are not to be construed as limiting the scope of the present
invention.
Brief Description of the Drawings
In the following, preferred embodiments of the invention will be explained in
greater
detail by making reference to the drawings in which:
Figure 1 schematically shows a cartridge holder with a needle assembly
attached
thereto in a longitudinal cross sectional illustration,
Figure 2 an isolated cross section of the receptacle of the needle
assembly along
A-A according to Figure 1,
Figure 3 an isolated cross-sectional illustration of the needle holder
along A-A,
Figure 4 the needle assembly according to Figure 2 and the cartridge
holder
according to Figure 3 in final assembly configuration with inter-engaging
fastening
means, and

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13
Figure 5 the assembly according to Figure 4 in a twisted and disengaged
configuration.
Detailed Description
In Figure 1, a cartridge holder subassembly is illustrated in a longitudinal
cross section.
The needle assembly 12 substantially comprises a cup-shaped receptacle 14
having a
bottom section 16 and a substantially cylindrical and circumferential sidewall
15. In the
centre of the bottom section 16, a piercing element, typically in form of an
injection
needle 18 is embedded having a distal tip 22 and a proximal tip 20. By way of
the
proximal tip 20, the needle 18 penetrates a pierceable septum of a cartridge,
which is
not explicitly illustrated here.
The cartridge holder 10 forms part of a housing of the not further illustrated
drug
delivery device. At its lower, distal section, the cartridge holder 10
comprises a neck
portion 11, that serves as support for the cup-shaped receptacle 14.
At its distal end section, the cartridge holder 10 comprises a radially
inwardly directed
circumferential flange portion 17 abutting with the bottom section 16 of the
needle
assembly 12. Furthermore, radial extension of the flange 17 defines a through
opening
19 for the proximal portion 20 of the needle 18.
As further illustrated in Figure 1, distal support section 11 of the cartridge
holder 10
comprises oppositely disposed and radially extending ribs 24, 25 that are in
engagement with radially inwardly protruding latching elements 26, 27 of the
sidewall 15
of the receptacle 14.
In the various cross sectional illustrations according to Figures 2, 3, 4 and
5, inter-
engagement of the fastening means 24, 25, 26, 27 is explained in greater
detail.

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14
As illustrated in Figures 2 and 3, the sidewall 15 of the receptacle 14 is of
oval or elliptic
shape and comprises radially inwardly protruding snapping or latching elements
26, 27.
Correspondingly, the support section 11 of the cartridge holder 10 comprises a

respective oval cross section but is smaller in diameter than the receptacle
14. Also, the
support section 11 comprises fastening elements 24, 25 in elongation of an
imaginary
long axis, which is horizontal in Figure 3.
Mutual distance of protrusions 24, 25 and of protrusions 26, 27 is chosen
such, that the
mutually corresponding fastening elements 24, 25, 26, 27 overlap in an axial
projection
when receptacle 14 and support section 11 are arranged in a nested or inter-
engaging
configuration. The illustrated overlapping of corresponding fastening elements
24, 25,
26, 27 will only be achieved and attained, if the long and short axes of the
oval
receptacle 14 as well as long and short axes of the support section 11 are
oriented
substantially parallel to each other. The different radial size of support
section 11 and
sidewall 15 allows for a relative twisting motion between the receptacle 14
and the
support section 11, at least within pre-defined margins.
Said margins are chosen in such a way and can be modified by appropriately
adapting
the overall circumferential geometry of receptacle 14 and support section 11
or by
modifying their respective inner or outer diameters. However, by twisting the
receptacle
14 counter-clockwise, the configuration as illustrated in Figure 4 can be
converted into a
release configuration as shown in Figure 5.
By way of twisting the receptacle 14 relative to the support section of the
cartridge
holder, the radial distance of mutually corresponding fastening means is
changed in
such a way, that the fastening elements 24, 26 and 25, 27 do no longer overlap
in an
axial projection. Consequently, cartridge holder 10 and needle assembly 12 are
no
longer positively engaged and the cup-shaped receptacle 14 can be removed from
the
cartridge holder 10.

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List of Reference Numerals
10 cartridge holder
11 support section
5 12 needle assembly
14 receptacle
15 sidewall
16 bottom section
17 flange
10 18 needle
tip
22 tip
24 rib
rib
15 26 latching element
27 latching element

Representative Drawing
A single figure which represents the drawing illustrating the invention.
Administrative Status

For a clearer understanding of the status of the application/patent presented on this page, the site Disclaimer , as well as the definitions for Patent , Administrative Status , Maintenance Fee  and Payment History  should be consulted.

Administrative Status

Title Date
Forecasted Issue Date Unavailable
(86) PCT Filing Date 2011-12-08
(87) PCT Publication Date 2012-06-21
(85) National Entry 2013-06-11
Dead Application 2017-12-08

Abandonment History

Abandonment Date Reason Reinstatement Date
2016-12-08 FAILURE TO REQUEST EXAMINATION
2016-12-08 FAILURE TO PAY APPLICATION MAINTENANCE FEE

Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Application Fee $400.00 2013-06-11
Registration of a document - section 124 $100.00 2013-09-18
Maintenance Fee - Application - New Act 2 2013-12-09 $100.00 2013-11-22
Maintenance Fee - Application - New Act 3 2014-12-08 $100.00 2014-11-24
Maintenance Fee - Application - New Act 4 2015-12-08 $100.00 2015-11-05
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
SANOFI-AVENTIS DEUTSCHLAND GMBH
Past Owners on Record
None
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
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Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Abstract 2013-06-11 2 73
Claims 2013-06-11 4 115
Drawings 2013-06-11 3 37
Description 2013-06-11 15 645
Representative Drawing 2013-07-25 1 7
Cover Page 2013-09-18 2 46
PCT 2013-06-11 5 134
Assignment 2013-06-11 5 139
Assignment 2013-09-18 2 105